The PsoTeenQOL - Preliminary Reliability and Validity

Psoriasis Clinical Trial

Official title:

The PsoTeenQOL - Preliminary Reliability and Validity of a Health-related Quality of Life Questionnaire for Adolescents With Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358914
• Other study ID #: HRQOL hos unge med psoriasis
• Status: Completed
• Start date: February 20, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: April 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to develop and provide preliminary reliability and validity of a questionnaire to measure Health-related Quality of Life (HRQOL) in adolescents with psoriasis. To the best of our knowledge, this will be the first psoriasis-specific HRQOL instrument for use in adolescent patients. Data will be collected from a Danish population of adolescents with psoriasis (12-17 years), as well as from parents of adolescents with psoriasis, and a group of adolescents without psoriasis.

Description:

The present study will examine the psychometric properties of a preliminary 41-item version of the PsoTeenQOL. The preliminary PsoTeenQOL has been developed based on qualitative interviews of adolescents (12-17 years) with psoriasis, their parents, and health professionals working within the field, as well as literature reviews and existing questionnaires. Face and content validity has been established through subsequent cognitive interviews with the target group.

Exploratory factor analysis (EFA) and analysis of differential item functioning (DIF) will be used to further refine the PsoTeenQOL questionnaire by selecting the most appropriate items. In addition, indicators of reliability (internal consistency; test-retest reliability), validity (construct validity, criterion validity; discriminant validity), and responsiveness will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: January 31, 2019
• Est. primary completion date: January 15, 2019
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Either a) Subjects with psoriasis, b) Parents of adolescents 12-17 years with psoriasis, or c) Subjects without psoriasis

• Ability to read Danish and complete electronic survey

Exclusion Criteria:

• Inability to read Danish and complete electronic survey

Related Conditions & MeSH terms

• Psoriasis

Intervention

Other:
• No intervention
Completion of surveys

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus C

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Herlev and Gentofte Hospital, LEO Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine the psychometric properties of the PsoTeenQOL	Analyses will include exploratory factor analysis, examination of differential item functioning (DIF) and evaluation of indicators of reliability and validity of the instrument	Baseline and up to 3 months after first completion of questionnaire package
Secondary	Indicators of validity	Correlations and comparisons between PsoTeenQOL and similar non-psoriasis-specific instruments (Children's Dermatology Life Quality Index (CDLQI); Pediatric Quality of Life Inventory (PedsQL); WHO-5, proxy- and non-psoriasis control version of the PsoTeenQOL) as well as measures of disease severity (Self-assessed Simplified Psoriasis Index (saSPI), and Psoriasis Area Severity Index (PASI)).	Baseline
Secondary	Indicators of reliability	Internal consistencies (Cronbach's alpha), test-retest reliability and responsiveness of the PsoTeenQOL (change scores on the PsoTeenQOL as compared to the CDLQI and disease severity indicators)	Test-retest: 2 weeks (+/-3 days) after baseline; Responsiveness: 3 months after baseline